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On May 25, 2022, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of ivosidenib tablets in combination with azacitidine for IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Ivosidenib is a small molecular IDH1 inhibitor, already approved across multiple IDH1-mutated cancer types. This expanded approval follows results from the phase III AGILE trial (NCT03173248), previously summarized in a visual abstract on the AML Hub, in which ivosidenib plus azacitidine demonstrated significantly improved event-free survival, overall survival, and overall response rate compared with azacitidine plus placebo. The safety profile was favorable in both treatment arms, and the most common adverse events were febrile neutropenia, anemia, thrombocytopenia, and pneumonia (22.5%).
Servier. Servier announces FDA approval of TIBSOVO® (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. https://www.servier.us/fda-approval-tibsovo-aml. Published May 25, 2022. Accessed May 31, 2022.
Visual abstract | AGILE study of ivosidenib + azacitidine versus placebo + azacitidine in newly diagnosed patients with an IDH1 mutation
The AML Hub is happy to present a Visual Abstract representing key data from the phase III AGILE study,...
ASH 2017 | IDH inhibitors in mIDH1 and mIDH2 AML – Enasidenib monotherapy in previously untreated IDH2 mutated AML and Ivosidenib and enasidenib in combination with azacitidine in newly diagnosed IDH mutated AML
At the 59th American Society of...
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